Rapid HIV-test distribution program expands HIV testing in United States

August 2006

About 1 million people in the United States had HIV or AIDS at the end of 2003, but approximately one-quarter of them were unaware, according to the CDC.

Because a large number of people were unaware they had the disease, the CDC launched its Advancing HIV Prevention program, which worked to expand HIV testing by distributing rapid HIV-tests to organizations throughout the United States. The rapid HIV-test provides results within 30 minutes, compared with the two weeks of standard testing.

Between September 2003 and December 2005, the CDC distributed nearly 800,000 OraQuick Advance Rapid HIV-1/2 Antibody tests (OraSure Technologies) to 230 organizations. Among the 372,960 people that used the test, 4,650 were tested and confirmed positive for HIV.

Organizations that routinely test people for HIV, including state and local health departments, medical centers, community-based organizations and correctional facilities throughout 37 states, were able to participate in the rapid HIV-test distribution program between 2003 and 2004. Participation was limited to 21 states and the District of Columbia in 2005 due to funding constraints.

In order to participate in the program, organizations had to have proper quality-assurance plans; Clinical Laboratory Improvement Amendments certification; run periodic, random external quality controls; and use either blot tests or immunofluorescent analyses to confirm all positive rapid HIV-test results.

Results of the program

Two different methods were used to evaluate the use of the rapid HIV-test distribution program. First, participating organizations were asked to submit quarterly reports that identified the number of tests used for training purposes, external controls and diagnostic purposes. The reports also included confirmed results for those who tested positive with the rapid HIV-test.

For the second evaluation, researchers contacted 52 out of the 107 distribution coordinators by telephone in early 2006 to discuss the implementation process of the rapid HIV testing and the challenges of the testing program.

Of the 230 organizations participating, 128 submitted the quarterly reports, accounting for 606,951 of the tests distributed. Of those tests, 372,960 (61.4%) were given for diagnostic purposes, 60,294 (9.9%) were used for quality control and 25,378 (4.2%) were used for training. The remaining 148,319 tests had either not been used and returned to the CDC or expired.

Of all the rapid tests administered, 5,385 (1.4%) were positive for HIV; 4,650 (1.2%) of these were confirmed HIV positive using conventional testing methods. Of the 5,385 positive rapid tests, 4,262 of the clients received their confirmed results.

Of the participating coordinators, 43 of 48 said that rapid HIV-test distribution program helped their organizations test more people since the program provided extra tests and because a second visit was not required due to quick results.

Researchers suggest that testing for HIV may increase due to the rapid tests and that the rapid HIV-test distribution program enabled the HIV diagnosis for people who were previously undiagnosed.

The FDA approved six different rapid HIV tests, two of which can be used in non-laboratory environments.

Statistical data

The states with the highest known population of people with AIDS or HIV were given the most tests. The breakdown of tests distributed within some of the states includes: 124,435 in California; 113,800 in New York; 47,000 in Florida; 43,200 in New Jersey; 39,300 in Massachusetts; and 33,400 in the District of Columbia.

In 2004, 11,806 white people were diagnosed with HIV, an increase from 11,242 in 2001. For black people, 19,206 were diagnosed with HIV, a decrease from 21,556 people diagnosed in 2001. Also in 2004, 6,970 Hispanic people (down from 7,714 in 2001); 394 Asian/Pacific Islander (up from 279 in 2001); and 208 American Indian/Alaska Native (up from 171 in 2001) people were diagnosed with HIV.

Most transmission in males was through male-to-male sexual contact (18,203) followed by heterosexual contact (4,581), transmission through intravenous drug use (3,828) and both male-to-male sexual conduct and intravenous drug use (1,372). Most females got HIV through heterosexual contact (8,102) followed by intravenous drug use (2,134).

These data are approximations resulting from count modification of reported cases, according to the CDC. Adjustments occur because of delays in reports and the redistribution of cases in people that were not yet diagnosed. The CDC reported all statistical estimations at the end of 2004.

For more information:

• CDC. Rapid HIV test distribution – United States, 2003-2005. MMWR. 2006;55:673-676.
• Visit CDC’s Web site for more about the report at www.cdc.gov/hiv/stats/2004surveillancereport.pdf.